FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Biocontainment: Understanding Biosafety Levels
    Biocontainment: Understanding Biosafety Levels

    This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.

  • A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities
    A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities

    This article presents a new scale for measuring the risk of compound carryover in shared facilities based on the process capability of a cleaning process that can be used to evaluate the probability of cross-contamination by compounds manufactured in a shared facility or equipment train.

  • What To Do When Your CMO Has To Transfer Your Product To A New Facility
    What To Do When Your CMO Has To Transfer Your Product To A New Facility

    You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change.

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PHARMA OUTSOURCING WHITE PAPERS

Manufacturing Process Scale-up For Phase III Manufacturing Process Scale-up For Phase III

Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?

Managing Demand Uncertainty In Biologics Production Managing Demand Uncertainty In Biologics Production

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

Managing Demand Uncertainty In Biologics Production

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

Microemulsion Capsule Technology To Optimize Drug Delivery
White Paper: Microemulsion Capsule Technology To Optimize Drug Delivery
A World Of Opportunities: Your Focused Field Guide For Specialty Transport To Emerging Markets

What documentation and steps are required to clear a product shipment for entry into China? What is the ability for major airports in Brazil to store refrigerated products while they are awaiting customs clearance?

Liquid Filled And Sealed Hard Gelatin Capsules
White Paper: Liquid Filled And Sealed Hard Gelatin Capsules
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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Challenges Of Pharmaceutical Temperature Control Distribution

A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product. 

White Paper: Introduction To Cross Flow Filtration

The purification of biological therapeutics generally utilizes both membrane and chromatographic separations. Membrane separations are complementary to chromatography and offer a number of key benefits: they are fast, robust, and can bring greater effectiveness to the key stages of bioprocessing, for example, by concentrating and washing feedstreams prior to chromatography

How To Achieve Good Mixing Fluid Results In 3 Minutes Or Less

The time it takes to mix fluids in disposable bags under different operating conditions is a key issue for many process developers. In many situations, this can be attained in three minutes or less.

Mixing And Heating-Cooling Characterization Data For The Xcellerex XDM 50 Single-Use Mixer

This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM 50 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

  • Ozonolysis Development Solutions For Safety Studies And Scale Up
    Ozonolysis Development Solutions For Safety Studies And Scale Up

    Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.

  • Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?
    Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?

    As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.

  • Six Myths About Serialization
    Six Myths About Serialization

    Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  • 5 ADC Manufacturing Challenges You Need To Know
    5 ADC Manufacturing Challenges You Need To Know

    Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.

  • Control Strategy For Potential Genotoxic Impurities (PGI)
    Control Strategy For Potential Genotoxic Impurities (PGI)

    The concept of Genotoxic Impurities (GI) and Potential Genotoxic Impurities (PGI) is defined in the ICH M7 (2014) and EMA (2006) guidelines. The focus of these guidelines are on DNA reactive substances – those when present at low levels have a potential to directly cause DNA damage and lead to mutations, thereby potentially causing cancer. For late stage compounds and marketed products, acceptable increased cancer risk is set at a theoretically calculated Threshold of Toxicological concern (TTC) level of 1.5 mg/day.

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OUTSOURCING EVENTS

The Impact of "Brexit" On Clinical Research – An Operational Readiness Primer August 24, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Manufacturing Quality Agreements- Actionable Top Tips for Ensuring Consistent Success August 30, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement September 6, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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